Director, Clinical Quality Assurance – CQA

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Create, maintain, and execute study-specific Clinical Quality Audit Plans for designated clinical programs and trials to ensure the implementation of an Audit Program that is appropriate for each phase.

• Act as the Quality representative in cross-functional clinical program meetings and Clinical Study Team activities, offering expert Quality guidance on GCP compliance to internal teams.

• Recognize, address, or escalate clinical quality risks by utilizing GCP expertise and best practices throughout all stages of clinical development.

• Maintain oversight of programs and encourage proactive quality management through quality-related tasks concerning vendor management, study execution, and research activities.

• Draft and/or evaluate QMS controlled documents, which may comprise standard operating procedures (SOPs) in line with relevant regulatory standards (e.g., ICH E6, FDA, EMA, MHRA, and local regulations).

• Supervise the timely and appropriate handling of Deviations, Investigations, and related procedures.

• Engage in risk review meetings and assess study Risk Management processes.

• Conduct quality assurance reviews of essential documents, including Clinical Protocols, Study Plans/Manuals, and Investigator Brochures, to ensure quality, accuracy, and completeness.

• Collaborate with both internal and external stakeholders to effectively manage GCP quality issues, CAPAs, and change controls.

• Propose process enhancements to integrate compliance into the design and implementation of clinical activities.

• Actively contribute to the development and execution of the Inspection Readiness/Management program to facilitate inspections by competent authorities for sponsors, clinical sites, and vendors.

⛳️ Requirements

• A minimum of a Bachelor's degree in a STEM field (Science, Technology, Engineering, and Math) or an allied medical field (such as Nursing or Pharmacy).

• At least seven (7) years of experience in pharmaceutical, biotech, or medical device GCP Quality Assurance (QA), Quality Management, or Clinical Compliance within Phase 1 to 4 clinical trials, including non-interventional studies (experience in immunology trials is highly preferred).

• Strong understanding and interpretation of global GxP regulations in drug development from pre-clinical phases to post-marketing safety, particularly those from the U.S. FDA/EU and ICH regulations and guidelines.

• Extensive and direct experience with competent authority inspections, such as US FDA GCP BIMO Inspections (for Sponsors, CROs, and/or Clinical Investigators), Pre-Approval Inspections (PAIs), etc.

• Proven and progressive leadership experience in motivating teams to proactively achieve strong operational outcomes and exceed client expectations.

• In-depth knowledge of the interrelationships among various Quality functions (such as CMC Quality, Quality Systems, Audit Management, Vendor Management) and other business areas (including Biostatistics, Clinical Development, Clinical Operations, Clinical Laboratory, CMC Operations, Data Management, Drug Safety and Pharmacovigilance, Regulatory, Supply Chain, and Program Management) to act as an effective business partner.

🏝️ Benefits

• Equity and other compensation forms may be included in a comprehensive total compensation package.

• A full suite of medical, dental, vision, 401k, and additional benefits.

• Unlimited paid time off.

• Parental leave.